Foresight Intracardiac Echocardiography System (ICE)

Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Intracardiac echocardiography imaging

• Registration Number: NCT03239444
• Lead Sponsor: Conavi

Brief Summary

This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.

Detailed Description

The study will recruit 10 patients at a single center.

Study Timeline

• Study Start: 2017-04-24
• Status Verified: 2017-07
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-04
• Primary Completion: 2018-12-24
• Study Completion: 2018-12-24
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patient is at least 18 years old.
• Patient is undergoing an atrial fibrillation ablation procedure.
• Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
• Patient provides informed, written consent for participation in the study.

Exclusion Criteria

• Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician/study investigator performing the procedure).
• Patients in whom transseptal puncture is relatively contraindicated.
• Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
• Women of child bearing potential, in whom pregnancy cannot be excluded.
• Patients unable to grant informed, written consent for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assigned Intervention	Intracardiac echocardiography imaging	Device: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure.

Primary Outcome Measures

Name	Time	Method
Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.	For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.	The ability of the study device to identify the atrial septum during transseptal puncture will be evaluated by the physician on the day of the procedure and captured in the individual case report form. This will be based on the objective finding of whether the transseptal puncture was performed (Yes or No) under study device guidance. This information will be gathered for each patient in the individual case report form and presented qualitatively and as quantitative measures (percentage success).

Secondary Outcome Measures

Name	Time	Method
Collection of first human images with Conavi's Foresight System.	An individual physician satisfaction survey will be completed for each case on the day of the procedure.	The Conavi's Foresight System will be utilized to capture images of relevant human cardiac anatomical landmarks (e.g. crista terminalis, tricuspid valve, coronary sinus) while the catheter will be manipulated inside the heart during the procedure. The physician satisfaction survey will ask the physician to specifically tabulate structures that could be identified in a binary yes/no format.; This kind of information will be gathered for each patient in the individual physician satisfaction surveys and presented qualitatively.

Trial Locations

Locations (1)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada